Do you develop or implement a new medical technology?
Medical technologies require constant improvements and innovations, including research and development, close co-operation with patients, health care providers and payers. These specific characteristics of medical technology industry imposes a need for detailed assessments and qualified decision making. No matter whether you need to convince an internal board, your investors or a public funding body, the systematic evaluation of economic and social impacts provides evidence for decision making.
To commercialise a new medical device, it is essential to be fully compliant with regulatory requirements and it is needed to prepare a medical device conformity assessment process.
HTA model refers to the systematic evaluation of properties, effects,and/or impacts of health technology to evaluate the social, economic, organizational, and ethical issues of a health intervention or health technology. HTA Framework will follow EU HTA Regulation 2021/2282 on health technology assessment and amending Directive2011/24/EU to enable production of high quality HTA information instructured format.
We prepare these models:
• Cost-effectiveness analysis, Cost-utility analysis, Cost-benefit analysis
• Budget impact models
• Cost-consequence analyses
• Asset valuation models
• Value-based pricing models
The CBA method evaluates the effects of investment decisions on all actors involved. The advantage of using this method is that the benefits, but also the costs (negative impacts) do not necessarily have to be expressed only in money, but also expressed by qualitative parameters (for example, in the form of social, environmental or other qualitative metrics). We choose a suitable method and convert advantages into financial values. Then, the impacts can be effectively assessed.
We can also offer preparation some model od commercialization (IP, licensing etc.). Market size, customer characterization, ability or willingness to pay, current state of the market and active competitors and their products are key input for business and cash flow modelling. Comprises key part of Business Model Canvas tool helps with capturing and organizing key aspects of your business idea. This helps to clarify business model and create a clear plan for a venture. In combination with system dynamics modelling method, result is a business model quantified in the form of system dynamics, which will supply cashflows for valuation according to founders or investors assumptions and translate them into exact valuation scenario immediately.
• Epidemiologic, humanistic, and economic burden of a disease
• Treatment guidelines and patterns in clinical practice
• Clinical and cost-effectiveness of comparator treatments
• Best practices in economic modelling methods in a disease area
• Economic model inputs including resource use, cost, and utility estimates
These results may be used as supplemental evidence as input to economic models, or in some cases, to support HTA submissions.
Whether your goal is to gain internal buy-in, secure investments, or attract public funding,our systematic evaluation of economic and social impacts offers compelling evidence foryour decision-making needs.
When it comes to bringing a new medical device to market, strict adherence to regulatory requirements is paramount. Our services encompass every facet of the medical device conformity assessment process:
• Regulatory strategy and CE mark of conformity
• Technical documentation and compliance
• Quality management system (QMS) implementation
We thoroughly analyze your regulatory needs, providing a comprehensive view of available options for compliance and market access.
We excel in navigating conformity assessments, acting as your reliable liaison with notified bodies, ensuring you’re never alone in your regulatory journey.
Our Regulatory Strategy assessments extend beyond borders, covering EU MDR Regulation (EU) 2017/745, FDA guidelines, and more, allowing you to expand your market confidently.
• Ensuring compliance with international standards and MDCG guidelines, making GSPR (General Safety and Performance Requirements) adherence effortless
• Covering a wide range, from usability analysis (IEC 62366-1) to pre-clinical and biological evaluation (ISO 10993-1), including technical safety evaluation(IEC 60601-1), risk analysis (ISO 14971), user manuals, software descriptions (IEC 62304), clinical evaluation, post-market clinical follow-up, and vigilance
• Comprehensive assessment of your testing needs, including electrical, biological, and clinical safety testing. We also consider retesting requirements, ensuring you stay ahead of evolving standards
• Personalized approach: We begin with individual interviews to create QMS processes tailored to your unique needs
• Optimization focus: Our goal isn’t just implementation; we aim to maximize efficiency, ensuring your QMS processes are not only compliant but also optimized for superior performance
• ISO 13485 alignment: Our expertise ensures seamless alignment with ISO13485 standards, giving you a competitive edge through internationally recognized quality management practices